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Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension

Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension

Recruiting
18-80 years
All
Phase 1

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Overview

Part 1 : To evaluate the safety of single-dose KK3910 in healthy volunteers. Part 2 : To evaluate the safety of multiple-dose KK3910 in patients with essential hypertension.

Eligibility

Inclusion Criteria: Part 1

  • Voluntary consent to participate in this study must be given (in writing)
  • Japanese or non-Asian healthy men 18 to < 55 years at the time of informed consent ( Japanese healthy men 65 to < 80 years for the elderly cohort)
  • BMI is within the specified range at screening

Inclusion Criteria: Part 2

  • Voluntary consent to participate in this study must be given (in writing)
  • Japanese patients with essential hypertension, aged 18 to <65 years at the time of informed consent
  • BMI is within the specified range at screening

Exclusion Criteria: Part 1

  • History of any respiratory disease, heart disease, gastrointestinal disease, renal disease, liver disease, psychiatric disorder, autoimmune disease, or malignant tumor that may affect assessments in the study, as judged by principal investigator or subinvestigator.
  • History of or current drug allergy
  • History of or current alcoholism or drug addiction
  • Smoking within the specified period
  • infection within the specified period
  • Any condition judged by the investigator or subinvestigator to be unsuitable for participation in the study

Exclusion Criteria: Part 2

  • History of any respiratory disease, heart disease, gastrointestinal disease, renal disease, liver disease, psychiatric disorder, autoimmune disease, or malignant tumor that may affect assessments in the study, as judged by principal investigator or subinvestigator.
  • History or of current drug allergy
  • History of or current alcoholism or drug addiction
  • Pregnant or breastfeeding patients, or patients willing to have a child during the study
  • Smoking within the specified period
  • infection within the specified period
  • Any condition judged by the investigator or subinvestigator to be unsuitable for participation in the study

Study details
    Healthy Volunteers Essential Hypertension

NCT06823947

Kyowa Kirin Co., Ltd.

15 May 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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